Healstone Biotech Inc ℅ Joe Shia, Director LSI International Inc. … · 2019. 9. 9. · 2...

August 7, 2019

Healstone Biotech Inc ℅ Joe Shia, Director LSI International Inc. 504 East Diamond Ave. Suite I Gaithersburg, MD 20877 Re: K191841

Trade/Device Name: Accurate Multi Panel Drug Urine Test Cup Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NGL, PTH, NFV, NFY, PTG, QBF, NGG, QAW, NGM, NFW Dated: July 5, 2019 Received: July 9, 2019

Dear Joe Shia: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

K191841 - Joe Shia Page

2

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

James.Mullally

Typewritten Text

k191841

1

510(k) SUMMARY

K191841

1 Date August 7, 2019

2 Submitter Healstone Biotech Inc.

650-655 W Kent N.

Vancouver, BC V6P6T7

Canada

3 Contact

Person

Joe Shia

LSI International Inc.

504 East Diamond Ave., Suite F

Gaithersburg, MD 20878

Telephone: 240-505-7880

Fax: 301-916-6213

Email: [email protected]

4 Device Name Accurate® Multi Panel Drug Urine Test Cup

5 Classification Class II

Product Code

Target Drug

Regulation Section Panel

NFT

Amphetamine (AMP)

862.3100, Amphetamine Test

System

Toxicology

NGL

Buprenorphine (BUP)

862.3650, Opiate Test System Toxicology

PTH

Secobarbital (BAR)

862.3150, Barbiturate Test

System

Toxicology

NFV

Oxazepam (BZO)

862.3170,

Benzodiazepine Test System

Toxicology

NFY

Cocaine (COC)

862.3250, Cocaine Test System Toxicology

PTG

2-ethylidene-1,5-

dimethyl-3,3-

diphenylpyrrolidine

(EDDP)

862.3620, Methadone Test System Toxicology

NGG

Methamphetamine

(MET)

862.3610,

Methamphetamine Test System

Toxicology

NGG

Methylenedioxymetha

mphetamine (MDMA)

862.3610,

Methamphetamine Test System

Toxicology

NGL 862.3650, Opiate Test System Toxicology

2

Morphine (MOP/OPI)

PTG

Methadone (MTD)

862.3620, Methadone Test System Toxicology

NGL

Oxycodone (OXY)

862.3650, Opiate Test System Toxicology

NGM

Phencyclidine (PCP)

Unclassified, Enzyme

Immunoassay Phencyclidine

Toxicology

QBF

Propoxyphene (PPX)

862.3700 Propoxyphene test

system.

Toxicology

QAW

Nortriptyline (TCA)

862.3910 Tricyclic antidepressant

drugs test system

Toxicology

NFW

Marijuana (THC 50)

862.3870, Cannabinoids Test

System

Toxicology

6 Predicate

Device

K182701

Wondfo T-Cup® Multi-Drug Urine Test Cup

7. Intended Use

Accurate Multi Panel Drug Urine Test Cup tests are competitive binding, lateral flow

immunochromatographic assays for qualitative and simultaneous detection of Amphetamine,

Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine,

Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone,

Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier) Cut-off level

Amphetamine (AMP) 1000 ng/mL

Buprenorphine (BUP) 10ng/mL

Secobarbital (BAR) 300 ng/mL

Oxazepam (BZO) 300 ng/mL

Cocaine (COC) 300 ng/mL

2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL

Methamphetamine (MET) 1000 ng/mL

Methylenedioxymethamphetamine (MDMA) 500 ng/mL

Morphine (MOP 300/OPI 2000) 300 ng/mL or 2000 ng/mL

Methadone (MTD) 300 ng/mL

Oxycodone (OXY) 100 ng/mL

Phencyclidine (PCP) 25 ng/mL

Propoxyphene (PPX) 300 ng/mL

Nortriptyline (TCA) 1,000 ng/mL

Marijuana (THC 50) 50 ng/mL

3

Accurate Multi Panel Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only

one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic

use only.

The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam,

Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to

distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment

should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate

chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

8. Device Description

Accurate® Multi Panel Drug Urine Test Cup are immunochromatographic assays that use a lateral flow

system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-

ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine,

Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human

urine. Each Accurate® Multi Panel Drug Urine Test Cup device consists of a test cup and a package insert.

Each test cup is sealed with desiccant in an aluminum pouch.

9. Substantial Equivalence Information

Item Proposed Device Predicate

(K182701)

Indication(s) for

use

For the qualitative determination of Amphetamine,

Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-

1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine,

Methylenedioxymethamphetamine, Morphine, Methadone,

Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and

Marijuana in human urine.

Same

Methodology Competitive binding, lateral flow immunochromatographic assay

based on antigen-antibody reaction

Same

Type of Test Qualitative Same

Specimen Type Human urine Same

Target Drug and

Cut Off Values

Target Drug Cutoff (ng/mL) Same

Amphetamine (AMP) 1000

Buprenorphine (BUP) 10

Secobarbital (BAR) 300

Oxazepam (BZO) 300

Cocaine (COC) 300

2-ethylidene-1,5-dimethyl-3,3-

diphenylpyrrolidine (EDDP)

300

Methamphetamine (MET) 1000

http://www.jb51.net/office/word/44745.html


4

Methylenedioxymethamphetamine (MDMA) 500

Morphine (MOP 300/OPI 2000) 2000 or 300

Methadone (MTD) 300

Oxycodone (OXY) 100

Phencyclidine (PCP) 25

Propoxyphene (PPX) 300

Nortriptyline (TCA) 1000

Marijuana (THC 50) 50

Configurations Test cup Same

Intended Use For over-the-counter use Same

10. Test Principle

Accurate® Multi Panel Drug Urine Test Cup is a rapid test for the qualitative detection of Amphetamine,

Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine,

Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone,

Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in urine samples. They are lateral flow

chromatographic immunoassay. When urine sample is added to the cup device, urine is absorbed into the

test strip and migrates upwards by capillary action. If the concentration of target drug presented in the

urine sample is below the cutoff level, the target drug will not saturate the binding sites of its specific

monoclonal antibody-coated particles. The antibody-coated particles will then be captured by

immobilized drug-conjugate and a visible colored band will be formed on the test line region. If the

concentration of target is beyond the cutoff level, the target drug will saturate the binding sites of its

specific monoclonal antibody-particles, thus the antibody-coated particles will not be captured by

immobilized drug-conjugate hence no colored band will be formed on the test line region.

A band should be formed on the control line region regardless of the presence of target drug or metabolite

in the sample to indicate that the tests have been performed properly.

11. Performance Characteristics

1. Analytical Performance

a. Precision

Precision studies were carried out for samples with concentrations of -100%cut off, -75%cut off, -

50%cut off, -25%cut off, +25%cut off, +50%cut off, +75%cut off and +100%cut off. For each

concentration, tests were performed two runs per day for 25 days. The results obtained are

summarized in the following table.

Accurate® Multi Panel Drug Urine Test Cup BUP

Concentration by

LC/MS

(ng/mL)

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

19.1 16.1 15.2 12.9 9.4 7.1 5.4 2.4 0



5

Lot Number

Lot I 0-/50+ 0-/50+ 0-/50+ 1-/49+ 26-/24+ 48-/2+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 1-/49+ 22-/28+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 2-/48+ 20-/30+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup PCP

Concentration by

LC/MS

(ng/mL)

Lot Number

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

50.3 43.1 36.2 30.4 25.0 17.9 12.2 6.4 0

Lot I 0-/50+ 0-/50+ 0-/50+ 1-/49+ 24-/26+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 1-/49+ 26-/24+ 48-/2+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 1-/49+ 21-/29+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup THC

Concentration by

LC/MS

(ng/mL)

Lot Number

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

100.8 88.6 72.9 65.8 50.2 39.5 25.2 12.6 0

Lot I 0-/50+ 0-/50+ 0-/50+ 1-/49+ 24-/26+ 47-/3+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 2-/48+ 28-/22+ 48-/2+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 3-/47+ 24-/26+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup OXY

Concentration by

LC/MS

(ng/mL)

Lot Number

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

200.3 170.6 150.1 118.5 98.4 77.9 52.5 28.3 0

Lot I 0-/50+ 0-/50+ 0-/50+ 2-/48+ 23-/27+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 2-/48+ 22-/28+ 47-/3+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 2-/48+ 21-/29+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup BAR

Concentration by

LC/MS

(ng/mL)

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

645.0 510.9 437.8 394.7 270.1 235.5 161.8 77.9 0





6

Lot Number

Lot I 0-/50+ 0-/50+ 0-/50+ 1-/49+ 24-/26+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 2-/48+ 19-/31+ 47-/3+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 1-/49+ 23-/27+ 48-/2+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup BZO

Concentration by

LC/MS

(ng/mL)

Lot Number

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

580.3 530.3 488.3 386.6 307.9 247.0 142.3 71.8 0

Lot I 0-/50+ 0-/50+ 0-/50+ 0-/50+ 24-/26+ 48-/2+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 2-/48+ 21-/29+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 2-/48+ 22-/28+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup EDDP

Concentration by

LC/MS

(ng/mL)

Lot Number

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

571.3 498.7 430.7 358.5 300.7 222.8 142.4 79.5 0

Lot I 0-/50+ 0-/50+ 0-/50+ 1-/49+ 20-/30+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 1-/49+ 22-/28+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 1-/49+ 20-/30+ 50-/0+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup MTD

Concentration by

LC/MS

(ng/mL)

Lot Number

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

588.6 514.8 471.0 393.1 314.6 223.5 140.9 74.6 0

Lot I 0-/50+ 0-/50+ 0-/50+ 0-/50+ 22-/28+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 1-/49+ 24-/26+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 0-/50+ 22-/28+ 50-/0+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup MOP

Concentration by

LC/MS

(ng/mL)

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

591.7 504.6 470.3 384.0 289.0 244.9 163.6 74.0 0





7

Lot Number

Lot I 0-/50+ 0-/50+ 0-/50+ 0-/50+ 24-/26+ 50-/0+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 0-/50+ 24-/26+ 50-/0+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 0-/50+ 23-/27+ 50-/0+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup PPX

Concentration by

LC/MS

(ng/mL)

Lot Number

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

626.7 534.8 433.6 364.2 308.6 225.3 159.1 79.4 0

Lot I 0-/50+ 0-/50+ 0-/50+ 0-/50+ 23-/27+ 48-/2+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 0-/50+ 22-/28+ 48-/2+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 1-/49+ 22-/28+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup MDMA

Concentration by

LC/MS

(ng/mL)

Lot Number

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

1208.1 863.1 711.1 592.8 516.6 375.2 259.9 124.1 0

Lot I 0-/50+ 0-/50+ 0-/50+ 1-/49+ 23-/27+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 2-/48+ 19-/31+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 0-/50+ 23-/27+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup TCA

Concentration by

LC/MS

(ng/mL)

Lot Number

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

2024.2 1727.6 1459.5 1276.1 1091.2 718.8 505.0 257.5 0

Lot I 0-/50+ 0-/50+ 0-/50+ 1-/49+ 21-/29+ 48-/2+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 2-/48+ 23-/27+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 2-/48+ 22-/28+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup OPI

Concentration by

LC/MS

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off





8

(ng/mL)

Lot Number

4166.3 3535.6 3077.2 2407.8 2008.3 1611.8 1041.0 509.5 0

Lot I 0-/50+ 0-/50+ 0-/50+ 1-/49+ 23-/27+ 50-/0+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 0-/50+ 25-/25+ 48-/2+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 1-/49+ 23-/27+ 48-/2+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup COC

Concentration by

LC/MS

(ng/mL)

Lot Number

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

619.3 533.4 432.2 360.6 303.1 226.4 157.7 73 0

Lot I 0-/50+ 0-/50+ 0-/50+ 0-/50+ 20-/30+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 1-/49+ 22-/28+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 0-/50+ 24-/26+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup AMP

Concentration by

LC/MS

(ng/mL)

Lot Number

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

2015.9 1749.1 1496.0 1202.3 1091.8 789.2 532.7 270.3 0

Lot I 0-/50+ 0-/50+ 0-/50+ 0-/50+ 23-/27+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 2-/48+ 24-/26+ 48-/2+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 1-/49+ 25-/25+ 50-/0+ 50-/0+ 50-/0+ 50-/0+

Accurate® Multi Panel Drug Urine Test Cup MET

Concentration by

LC/MS

(ng/mL)

Lot Number

+100%

cutoff

+75%

cutoff

+50%

cutoff

+25%

cutoff

Cutoff -25%

cutoff

-50%

cutoff

-75%

cutoff

-100%

cut-off

1906.8 1629.3 1459.1 1229.8 949.7 733.1 491.1 236.2 0

Lot I 0-/50+ 0-/50+ 0-/50+ 0-/50+ 20-/30+ 50-/0+ 50-/0+ 50-/0+ 50-/0+

Lot II 0-/50+ 0-/50+ 0-/50+ 1-/49+ 19-/31+ 50-/0+ 50-/0+ 50-/0+ 50-/0+

Lot III 0-/50+ 0-/50+ 0-/50+ 0-/50+ 19-/31+ 49-/1+ 50-/0+ 50-/0+ 50-/0+

The following cutoff values are verified:

Target Drug Cut-off level




9

Amphetamine (AMP) 1000 ng/mL

Buprenorphine (BUP) 10 ng/mL

Secobarbital (BAR) 300 ng/mL

Oxazepam (BZO) 300 ng/mL

Cocaine (COC) 300 ng/mL

2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL

Methamphetamine (MET) 1000 ng/mL

Methylenedioxymethamphetamine (MDMA) 500 ng/mL

Morphine (MOP 300/OPI 2000) 2000 ng/mL or 300 ng/mL

Methadone (MTD) 300 ng/mL

Oxycodone (OXY) 100 ng/mL

Phencyclidine (PCP) 25 ng/mL

Propoxyphene (PPX) 300 ng/mL

Nortriptyline (TCA) 1000 ng/mL

Marijuana (THC 50) 50 ng/mL

b. Linearity

Not applicable

c. Stability

The devices are stable at 4-30℃ for 24 months based on real-time stability studies.

d. Interference

Potential interfering substances were added to drug-free urine sample and samples with target drugs

of -50% cutoff and +50% cutoff level.

Compounds that show no interference at a concentration of 100µg/mL are summarized in the

following table.

(±)-4-Methylephedrine Ecgonine methylester Oxalic acid

Acetaminophen β-Estradiol Oxolinic acid

Acetophenetidin Erythromycin Oxymetazoline

N-Acetylprocainamide Fenoprofen Papaverine

Acetylsalicylic acid Furosemide Penicillin G

Albumin (100 mg/dL) Gentisic acid Perphenazine

Aminopyrine Hemoglobin Phenelzine

Amoxicillin Hydralazine Prednisone

Ampicillin Hydrochlorothiazide (±)-Propranolol

Apomorphine Hydrocortisone Pseudoephedrine

10

Ascorbic acid O-Hydroxyhippuric acid Quinine

Aspartame 3-Hydroxytyramine Ranitidine

Atropine Ibuprofen Salicylic acid

Benzilic acid Isoproterenol

Serotonin (5-

Hydroxytyramine)

Benzoic acid Isoxsuprine Sulfamethazine

Bilirubin Ketamine Sulindac

Chloral hydrate Ketoprofen

Tetrahydrocortisone 3-

(β-Dglucuronide)

Chloramphenicol Labetalol

Tetrahydrocortisone 3-

acetate

Chlorothiazide Loperamide Tetrahydrozoline

Chlorpromazine Meperidine Thiamine

Cholesterol Meprobamate Thioridazine

Clonidine Methoxyphenamine Triamterene

Cortisone Nalidixic acid Trifluoperazine

(-)-Cotinine Naproxen Trimethoprim

Creatinine Niacinamide DL-Tryptophan

Deoxycorticosterone Nifedipine DL-Tyrosine

Dextromethorphan Norethindrone Uric acid

Diclofenac Noscapine Verapamil

Diflunisal (±)-Octopamine Zomepirac

Digoxin

e. Specificity

To test the specificity, drug metabolites and other components that are likely to cross-react in

urine samples were spiked into drug-free urine. These urine samples were tested using three lots

of each device.

Compounds that produced positive results are listed below.

BUP (Buprenorphine,

Cutoff=10 ng/mL)

Minimum concentration

required to obtain a

positive result (ng/mL)

% Cross-

Reactivity

Buprenorphine 10 100%

Buprenorphine -3-D-Glucuronide 160 6%

Norbuprenorphine 10 100%

Norbuprenorphine-3-D-Glucuronide 200 5%

Morphine 100000 (negative) Not detected

Oxymorphone 100000 (negative) Not detected

Hydromorphone 100000 (negative) Not detected

11

PCP (Phencyclidine)

(Phencyclidine,

Cutoff=25 ng/mL)




% Cross-

Reactivity

Phencyclidine 25 100%

4-Hydroxy Phencyclidine 12500 0.2%

THC

(11-nor-Δ9-THC-9-COOH,

Cutoff=50 ng/mL)




% Cross-

Reactivity

11-nor-Δ8-THC -9-COOH 30 167%

(-)-11-nor-9-carboxy-Δ 9-THC 50 100%

(±)-11-nor-9-Carboxy-Δ9-THC 50 100%

11-nor-Δ9-THC -carboxy glucuronide 100 50%

11-hydroxy-Δ9-Tetrahydrocannabinol 5,000 1%

Δ8- Tetrahydrocannabinol 1,300 4%

Δ9- Tetrahydrocannabinol 5,000 1%

Cannabinol 20,000 0.25%

Cannabidiol 100000(negative) Not Detected

OXY

(Oxycodone, Cutoff=100 ng/mL)




% Cross-

Reactivity

Ethyl Oxycodone 75,000 0.1%

Hydrocodone 5,000 2%

Hydromorphone 25,000 0.4%

Levorphanol 10,000 1%

Oxycodone 100 100%

Oxymorphone 200 50%

Dihydrocodeine 100000(negative) Not Detected

Codeine 100000(negative) Not Detected

Morphine 100000(negative) Not Detected

Acetylmorphine 100000(negative) Not Detected

Buprenorphine 100000(negative) Not Detected

Ethylmorphine 100000(negative) Not Detected

Thebaine 100000(negative) Not Detected

BAR

(Secobarbital, Cutoff=300ng/mL)




% Cross-

Reactivity

Alphenal 150 200%

Amobarbital 300 100%

12

Aprobarbital 250 120%

Butabarbital 2,500 12%

Butethal 100 300%

Butalbital 2,500 12%

Cyclopentobarbital 600 50%

Pentobarbital 250 120%

Phenobarbital 250 120%

Secobarbital 300 100%

BZO

(Oxazepam, Cutoff=300ng/mL)




% Cross-

Reactivity

Alprazolam 200 150%

a-Hydroxyalprazolam 1,260 24%

Bromazepam 1,560 19%

Chlordiazepoxide 1,560 19%

Clobazam 100 300%

Clonazepam 2,500 12%

Clorazepate dipotassium 200 150%

Desalkylflurazepam 400 75%

Diazepam 200 150%

Estazolam 2,500 12%

Flunitrazepam 400 75%

Midazolam 12,500 2.4%

Nitrazepam 100 300%

Norchlordiazepoxide 200 150%

Nordiazepam 400 75%

Temazepam 100 300%

Triazolam 2,500 12%

Demoxepam 2,000 15%

Flurazepam 500 60%

D,L-Lorazepam 1,560 20%

Oxazepam 300 100%

RS-Lorazepam glucuronide 160 188%

Delorazepam 100000 (negative) Not detected

EDDP

(2-ethylidene-1,5-dimethyl-3,3-

diphenylpyrrolidine, Cutoff = 300 ng/mL)




% Cross-

Reactivity

2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine 300 100%

Methadone >100000 Not detected

EMDP >100000 Not detected

13

Doxylamine >100000 Not detected

Disopyramide >100000 Not detected

LAAM (Levo-alpha-acetylmethadol) >100000 Not detected

Alpha Methadol >100000 Not detected

MTD

(Methadone, Cutoff=300ng/mL)




% Cross-

Reactivity

Methadone 300 100%

Doxylamine >100000 Not detected

EDDP >100000 Not detected

EMDP >100000 Not detected

LAAM >100000 Not detected

Alpha Methadol >100000 Not detected

MOP 300

(Morphine, Cutoff=300ng/mL)




% Cross-

Reactivity

Morphine 300 100%

Normorphine 300 100%

s-Monoacetylmorphine 300 100%

Codeine 300 100%

Ethyl Morphine 100 300%

Heroin 600 50%

Hydrocodone 10000 3%

Hydromorphone 500 60%

Morphinie-3-β-d-glucuronide 1000 30%

Thebaine 6,240 4.8%

Levorphanol 10000 3%

6-Monoacetylmorphine (6-MAM) 150 200%

6-acetylmorphine 400 75%

Dihydrocodeine 1000 30%

Normorphine >100000 Not detected

Oxycodone >100000 Not detected

Oxymorphone >100000 Not detected

Norcodeine >100000 Not detected

Procaine >100000 Not detected

PPX

(Propoxyphene, Cutoff=300ng/mL)




% Cross-

Reactivity

d-Propoxyphene 300 100%

14

d-Norpropoxyphene 300 100%

MDMA

(3,4-Methylenedioxymethamphetamine HCl,

Cutoff=500ng/mL)




% Cross-

Reactivity

3,4-Methylenedioxymethamphetamine (MDMA) 500 100%

3,4-Methylenedioxyamphetamine HCl (MDA) 3000 17%

3,4-Methylenedioxyethylamphetamine (MDEA) 300 167%

l-Methamphetamine 50000 1%

d-methamphetamine 100000(Negative) Not detected

d-amphetamine 100000(Negative) Not detected

l-amphetamine 100000(Negative) Not detected

TCA 1000

(Nortriptyline, Cutoff=1000ng/mL)




% Cross-

Reactivity

Chlorpheniramine maleate 50000 2%

Nortriptyline 1000 100%

Nordoxepine 1000 100%

Trimipramine 10000 10%

Amitriptyline 1500 66.7%

Promazine 50000 2%

Desipramine 1000 100%

Imipramine 1000 100%

Clomipramine 10000 10%

Doxepin 2000 50%

Maprotiline 100000(Negative) Not detected

Promethazine 100000(Negative) Not detected

Cyclobenzaprine 5000 20%

Norclomipramine 12500 8%

Duloxetine 10000 10%

COC

(Benzoylecgonine, Cutoff=300ng/mL)




% Cross-

Reactivity

Benzoylecgonine 300 100%

Cocaine 300 100%

Cocaethylene 300 100%

Ecgonine 300 100%

Ecgonine methyl ester 100000 (negative) Not detected

Norcocaine 100000 (negative) Not detected

15

AMP

(d-Amphetamine, Cutoff=1000ng/mL)




% Cross-

Reactivity

(+/-)-4-Hydroxyamphetamine 8000 12.5%

Methylenedioxyamphetamine(MDA) 400 250%

D,L-Amphetamine 1,000 100%

D-Amphetamine 1,000 100%

Diethylstilbestrol 5,000 20%

L-Amphetamine 50,000 2%

Phentermine 8,000 12.5%

β-Phenylethylamine 100000 1%

p-Hydroxynorephedrine 100000 1%

p-Hydroxyamphetamine 100,000 1%

d/l-Norephedrine 100,000 1%

d-Methamphetamine 50,000 2%

l-Methamphetamine 1,000 100%

Ephedrine 100000 (negative) Not detected

Methylenedioxymethamphetamine

(MDMA) 100000 (negative) Not detected

Phenylpropanolamine 100000 (negative) Not detected

Benzphetamine 100000 (negative) Not detected

l-Ephedrine 100000 (negative) Not detected

l-Epinephrine 100000 (negative) Not detected

d/l-Epinephrine 100000 (negative) Not detected

MET

(D(+)-Methamphetamine, Cutoff=1000ng/mL)




% Cross-

Reactivity

(+/-)3,4-Methylenedioxy-n-ethylamphetamine

(MDEA) 20,000 5%

(±)-MDMA 2,500 40%

d-Methamphetamine 1,000 100%

l-Methamphetamine 25,000 4%

d/l-Methamphetamine 1,000 100%

p-Hydroxymethamphetamine 10,000 10%

L-Amphetamine 75000 1.3%

β-Phenylethylamine 50000 2%

Mephetermine 50000 2%

Fenfluramine 50000 2%

D-Amphetamine 100000(negative) Not Detected

Chloroquine 100000(negative) Not Detected

16

(+/-)3,4-Methylenedioxyamphetamine (MDA) 100000(negative) Not Detected

Trimethobenzamide 100000(negative) Not Detected

d,l-Amphetamine 100000(negative) Not Detected

(1R,2S)-(-)-Ephedrine 100000(negative) Not Detected

l-phenylephrine 100000(negative) Not Detected

OPI

(Morphine, Cutoff=2000ng/mL)




% Cross-

Reactivity

Morphine 2000 100%

Codeine 1000 200%

Ethyl Morphine 2500 80%

Hydrocodone 5000 40%

Hydromorphone 25000 8%

Levorphanol 10000 20%

6-Monoacetylmorphine（6-MAM） 1500 133%

Morphine 3-β-D-glucuronide 2000 100%

Norcodeine 4000 50%

Normorphine 5000 40%

Oxymorphone 75000 3%

Thebaine 13000 15%

Heroin 5000 40%

s-Monoacetylmorphine 2000 100%

Dihydrocodeine 1500 133%

Nalorphine 5000 40%

6-acetylmorphine 2,500 80%

Procaine 100000(negative) Not Detected

Oxycodone 100000(negative) Not Detected

f. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity, urine samples with specific gravity from 1.000 to

1.035 were spiked with target drugs at +50% cutoff and -50% cutoff levels. Three operators tested

samples using test devices from three different lots. The results were all positive for samples at

+50% cutoff and all negative for samples at -50% cutoff, indicating that urine specific gravity

between 1.000 and 1.035 has no effect on the accuracy and precision of the test device.

To investigate the effect of urine pH, urine samples with pH value from 4 to 9 were spiked with

target drugs at +50% cutoff and -50% cutoff levels. Three operators tested samples using test

devices from three different lots. The results were all positive for samples at +50% cutoff and all

negative for samples at -50% cutoff, indicating that urine pH value between 4.0 and 9.0 has no

effect on the accuracy and precision of the test device.

17

2. Comparison Studies

The method comparison studies for Accurate® Multi Panel Drug Urine Test cup were performed in-

house with three operators.

Operators ran 80 (40 negative and 40 positive) unaltered urine samples. The samples were blind

labeled and compared to LC/MS or GC/MS results. The results are presented in the table below:

For Accurate® Multi Panel Drug Urine Test Cup:

BUP

Accurate

®

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

(Between -50%

and the Cutoff)

Near Cutoff

Positive by

LC/MS

(Between the

cutoff and

+50%)

High Positive

by LC/MS

(greater than

+50%)

Viewer A Positive 0 0 1 14 23

Negative 10 16 13 3 0

Viewer B Positive 0 0 3 14 23

Negative 10 16 11 3 0

Viewer C Positive 0 0 1 14 23

Negative 10 16 13 3 0

Discordant Results for BUP:

Viewer Sample Number LC/MS Result (ng/mL) Accurate Result

Viewer A MCP-BUP-A75 10.2 -



Viewer B MCP-BUP-A58 10.3 -



Viewer C MCP-BUP-A58 10.3 -



Viewer A MCP-BUP-A79 9.0 +

Viewer B MCP-BUP-A01 8.4 +



Viewer C MCP-BUP-A54 9.5 +

BAR

Accurate

®

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

Near Cutoff

Positive by

LC/MS

High Positive

by LC/MS

(greater than

+50%)

18

(Between -50%

and the Cutoff)

(Between the

cutoff and

+50%)


Negative 10 16 11 3 0


Negative 10 16 12 3 0


Negative 10 16 12 3 0

Discordant Results for BAR:


Viewer A MCP-BAR-A64 271.6 +



Viewer B MCP-BAR-A23 246.0 +

Viewer B MCP-BAR-A02 285.9 +

Viewer C MCP-BAR-A02 285.9 +

Viewer C MCP-BAR-A41 295.6 +

Viewer A MCP-BAR-A14 301.7 -



Viewer B MCP-BAR-A47 311.9 -



Viewer C MCP-BAR-A14 301.7 -



BZO

Accurate

®

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

(Between -50%

and the Cutoff)

Near Cutoff

Positive by

LC/MS

(Between the

cutoff and

+50%)

High Positive

by LC/MS

(greater than

+50%)


Negative 10 16 13 3 0


Negative 10 16 11 4 0


19

Negative 10 16 12 3 0

Discordant Results for BZO:


Viewer A MCP-BZO-A37 274.5 +

Viewer B MCP-BZO-A51 227.5 +



Viewer C MCP-BZO-A75 235.0 +

Viewer C MCP-BZO-A37 274.5 +

Viewer A MCP-BZO-A76 304.6 -



Viewer B MCP-BZO-A76 304.6 -




Viewer C MCP-BZO-A27 309.5 -



EDDP

Accurate®

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

(Between -

50% and the

Cutoff)

Near Cutoff

Positive by

LC/MS

(Between the

cutoff and

+50%)

High Positive

by LC/MS

(greater than

+50%)


Negative 10 16 13 3 0


Negative 10 16 13 3 0


Negative 10 16 13 2 0

Discordant Results for EDDP:


Viewer A MCP-EDDP-A07 254.8 +

Viewer B MCP-EDDP-A07 254.8 +

Viewer C MCP-EDDP-A21 245.1 +

Viewer A MCP-EDDP-A12 303.7 -



20

Viewer B MCP-EDDP-A38 302.4 -



Viewer C MCP-EDDP-A12 303.7 -

Viewer C MCP-EDDP-A20 316.7 -

MDMA

Accurate

®

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

(Between -50%

and the Cutoff)

Near Cutoff

Positive by

LC/MS

(Between the

cutoff and

+50%)

High Positive

by LC/MS

(greater than

+50%)


Negative 10 16 13 4 0


Negative 10 16 12 3 0


Negative 10 16 13 3 0

Discordant Results for MDMA:


Viewer A MCP-MDMA-A10 451.4 +

Viewer B MCP-MDMA-A48 379.2 +

Viewer B MCP-MDMA-A26 476.0 +

Viewer C MCP-MDMA-A10 451.4 +

Viewer A MCP-MDMA-A21 525.2 -




Viewer B MCP-MDMA-A78 532.6 -



Viewer C MCP-MDMA-A39 528.9 -



MOP 300

21

Accurate

®

Drug-Free

Low

Negative by

GC/MS (less

than -50%)

Near Cutoff

Negative by

GC/MS

(Between -50%

and the Cutoff)

Near Cutoff

Positive by

GC/MS

(Between the

cutoff and

+50%)

High Positive

by GC/MS

(greater than

+50%)


Negative 10 16 12 2 0


Negative 10 16 11 2 0


Negative 10 16 12 2 0

Discordant Results for MOP 300:

Viewer Sample Number GC/MS Result (ng/mL) Accurate Result

Viewer A MCP-MOP-A152 277.0 +


Viewer B MCP-MOP-A135 240.9 +



Viewer C MCP-MOP-A098 272.3 +


Viewer A MCP-MOP-A151 305.6 -


Viewer B MCP-MOP-A081 300.4 -


Viewer C MCP-MOP-A081 300.4 -


MTD

Accurate

®

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

(Between -50%

and the Cutoff)

Near Cutoff

Positive by

LC/MS

(Between the

cutoff and

+50%)

High Positive

by LC/MS

(greater than

+50%)


Negative 10 16 13 4 0


Negative 10 16 12 3 0


Negative 10 16 13 4 0

22

Discordant Results for MTD:


Viewer A MCP-MTD-A71 290.9 +

Viewer B MCP-MTD-A25 262.4 +

Viewer B MCP-MTD-A36 272.2 +

Viewer C MCP-MTD-A71 290.9 +

Viewer A MCP-MTD-A52 309.6 -




Viewer B MCP-MTD-A52 309.6 -



Viewer C MCP-MTD-A45 300.5 -




OXY

Accurate

®

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

(Between -50%

and the Cutoff)

Near Cutoff

Positive by

LC/MS

(Between the

cutoff and

+50%)

High Positive

by LC/MS

(greater than

+50%)


Negative 10 16 13 5 0


Negative 10 16 13 3 0


Negative 10 16 13 4 0

Discordant Results for OXY:


Viewer A MCP-OXY-A54 77.1 +

Viewer B MCP-OXY-A33 92.3 +

Viewer C MCP-OXY-A33 92.3 +

Viewer A MCP-OXY-A76 102.8 -




23


Viewer B MCP-OXY-A15 103.7 -



Viewer C MCP-OXY-A60 100.5 -




PCP

Accurate

®

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

(Between -50%

and the Cutoff)

Near Cutoff

Positive by

LC/MS

(Between the

cutoff and

+50%)

High Positive

by LC/MS

(greater than

+50%)


Negative 10 16 13 5 0


Negative 10 16 14 4 0


Negative 10 16 13 6 0

Discordant Results for PCP:


Viewer A MCP-PCP-A38 23.6 +

Viewer C MCP-PCP-A65 23.1 +

Viewer A MCP-PCP-A04 25.5 -





Viewer B MCP-PCP-A04 25.5 -




Viewer C MCP-PCP-A53 25.1 -





24


PPX

Accurate

®

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

(Between -50%

and the Cutoff)

Near Cutoff

Positive by

LC/MS

(Between the

cutoff and

+50%)

High Positive

by LC/MS

(greater than

+50%)


Negative 10 16 13 3 0


Negative 10 16 13 2 0


Negative 10 16 13 2 0

Discordant Results for PPX 300:


Viewer A MCP-PPX-A78 255.3 +

Viewer B MCP-PPX-A20 295.8 +

Viewer C MCP-PPX-A20 295.8 +

Viewer A MCP-PPX-A38 314.2 -



Viewer B MCP-PPX-A38 314.2 -

Viewer B MCP-PPX-A42 339.5 -

Viewer C MCP-PPX-A12 307.1 -

Viewer C MCP-PPX-A38 314.2 -

TCA

Accurate

®

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

(Between -50%

and the Cutoff)

Near Cutoff

Positive by

LC/MS

(Between the

cutoff and

+50%)

High Positive

by LC/MS

(greater than

+50%)


Negative 10 16 12 3 0


Negative 10 16 12 3 0

25


Negative 10 16 11 2 0

Discordant Results for TCA:


Viewer A MCP-TCA-A45 806.6 +

Viewer A MCP-TCA-A66 983.7 +

Viewer B MCP-TCA-A09 925.4 +

Viewer B MCP-TCA-A21 955.8 +

Viewer C MCP-TCA-A57 780.7 +



Viewer A MCP-TCA-A06 1070.1 -



Viewer B MCP-TCA-A33 1045.4 -



Viewer C MCP-TCA-A06 1070.1 -

Viewer C MCP-TCA-A05 1111.1 -

THC

Accurate

®

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

(Between -50%

and the Cutoff)

Near Cutoff

Positive by

LC/MS

(Between the

cutoff and

+50%)

High Positive

by LC/MS

(greater than

+50%)


Negative 10 16 13 2 0


Negative 10 16 13 3 0


Negative 10 16 12 2 0

Discordant Results for THC:


Viewer A MCP-THC-A80 39.1 +

Viewer B MCP-THC-A55 48.2 +

Viewer C MCP-THC-A48 40.2 +

Viewer C MCP-THC-A55 48.2 +

26

Viewer A MCP-THC-A59 50.5 -

Viewer A MCP-THC-A66 54.1 -

Viewer B MCP-THC-A53 52.2 -



Viewer C MCP-THC-A53 52.2 -

Viewer C MCP-THC-A79 57.5 -

AMP

Accurate

®

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

(Between -50%

and the Cutoff)

Near Cutoff

Positive by

LC/MS

(Between the

cutoff and

+50%)

High Positive

by LC/MS

(greater than

+50%)


Negative 10 16 11 2 0


Negative 10 16 10 3 0


Negative 10 16 12 3 0

Discordant Results for AMP:


Viewer A MCP-AMP-A60 906.4 +



Viewer B MCP-AMP-A47 789.6 +




Viewer C MCP-AMP-A10 923.2 +

Viewer C MCP-AMP-A26 965.0 +

Viewer A MCP-AMP-A56 1013.8 -

Viewer A MCP-AMP-A78 1180.9 -

Viewer B MCP-AMP-A49 1053.4 -



Viewer C MCP-AMP-A49 1053.4 -



27

COC

Accurate

®

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

(Between -50%

and the Cutoff)

Near Cutoff

Positive by

LC/MS

(Between the

cutoff and

+50%)

High Positive

by LC/MS

(greater than

+50%)


Negative 10 16 13 3 0


Negative 10 16 13 4 0


Negative 10 16 13 3 0

Discordant Results for COC:

Viewer Sample Number LC/MS Result Accurate Result

Viewer A MCP-COC-A75 267.4 +

Viewer B MCP-COC-A14 267.8 +

Viewer C MCP-COC-A38 291.6 +

Viewer A MCP-COC-A15 309.0 -



Viewer B MCP-COC-A50 302.3 -




Viewer C MCP-COC-A50 302.3 -



MET

Accurate

®

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

(Between -50%

and the Cutoff)

Near Cutoff

Positive by

LC/MS

(Between the

cutoff and

+50%)

High Positive

by LC/MS

(greater than

+50%)


Negative 10 16 14 4 0


Negative 10 16 13 3 0

28


Negative 10 16 13 4 0

Discordant Results for MET:


Viewer B MCP-MET-A27 846.8 +

Viewer C MCP-MET-A71 732.5 +

Viewer A MCP-MET-A50 1034.1 -




Viewer B MCP-MET-A39 1059.0 -



Viewer C MCP-MET-A50 1034.1 -




OPI 2000

Wondfo

Q-Cup

Drug-Free

Low

Negative by

LC/MS (less

than -50%)

Near Cutoff

Negative by

LC/MS

(Between -50%

and the Cutoff)

Near Cutoff

Positive by

LC/MS

(Between the

cutoff and +50%)

High Positive

by LC/MS

(greater than

+50%)


Negative 10 16 13 4 0


Negative 10 16 13 3 0


Negative 10 16 13 5 0

Discordant Results for OPI 2000:









29









Lay-user study:

184 males and 126 females tested Accurate® Multi Panel Drug Urine Test Cup Configuration 1

(including MOP 300); 178 male and 132 females tested Accurate® Multi Panel Drug Urine Test Cup

Configuration 2 (including MOP 2000 (OPI). They had diverse educational and professional

backgrounds and fluent in English and their age range from 20 to over 50. Urine samples were

prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking

drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by

LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant

was provided with the package insert, 1 blind labeled sample and a device. The results are

summarized below.

Lay-User Study Results for Accurate® Multi Panel Drug Urine Test Cup Configuration 1 (MOP 300):

Drugs % of Cutoff Number

of samples

Lay person results The percentage

agreement

(%)

No. of

Positive

No. of

Negative

Methamphetamine

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 1 19 95%

+25% Cutoff 20 18 2 90%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Cocaine

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 18 2 90%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Marijuana

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

30

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 17 3 85%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Morphine

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 1 19 95%

+25% Cutoff 20 20 0 100%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Oxazepam

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Amphetamine

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 1 19 95%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Oxycodone

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 18 2 90%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Methadone

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 1 19 95%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

MDMA

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

31

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 18 2 90%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Secobarbital

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 18 2 90%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Buprenorphine

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Phencyclidine

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 1 19 95%

+25% Cutoff 20 17 3 85%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Propoxyphene

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 1 19 95%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Tricyclic

Antidepressants

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

EDDP

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

32

-25% Cutoff 20 1 19 95%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Lay-User Study Results for Accurate® Multi Panel Drug Urine Test Cup Configuration 2 (MOP 2000

(OPI)):

Drugs % of Cutoff Number

of samples

Lay person results The percentage

agreement

(%)

No. of

Positive

No. of

Negative

Methamphetamine

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 1 19 95%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Cocaine

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 1 19 95%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Marijuana

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 18 2 90%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Morphine

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 1 19 95%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Oxazepam

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 1 19 95%

33

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Amphetamine

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Oxycodone

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Methadone

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 1 19 95%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

MDMA

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Secobarbital

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 1 19 95%

+25% Cutoff 20 18 2 90%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Buprenorphine

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 3 17 85%

34

+25% Cutoff 20 18 2 90%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Phencyclidine

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 17 3 85%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Propoxyphene

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Tricyclic

Antidepressants

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 1 19 95%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

EDDP

-100%Cutoff 20 0 20 100%

-75%Cutoff 20 0 20 100%

-50% Cutoff 20 0 170 100%

-25% Cutoff 20 2 18 90%

+25% Cutoff 20 19 1 95%

+50% Cutoff 20 40 0 100%

+75% Cutoff 20 20 0 100%

Participants were given surveys on the ease of understanding the instruction for use. All participants

indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading

analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

Clinical Studies:

Not applicable.

12. Conclusion

35

Based on the test principle and performance characteristics of the device including precision, cut-off,

interference, specificity, method comparison and lay-user studies of the devices, it’s concluded that

Accurate® Multi Panel Drug Urine Test Cup are substantially equivalent to the predicate devices.

Healstone Biotech Inc ℅ Joe Shia, Director LSI International Inc. … · 2019. 9. 9. · 2...

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